Takeda to distribute Y-mAbs' cancer antibody treatment in Israel

By The Science Advisory Board staff writers

December 4, 2020 -- Y-mAbs and Takeda Israel, a subsidiary of Takeda Pharmaceutical, have entered into an exclusive license and distribution agreement for the registration and commercialization in Israel of naxitamab-gqgk (Danyelza) and omburtamab.

Danyelz was approved by the U.S. Food and Drug Administration (FDA) on November 25, for the treatment of with relapsed/refractory high-risk neuroblastoma. Y-mAbs plans to resubmit an amended biologics license application for omburtamab for the treatment of pediatric patients with central nervous system/leptomeningeal metastasis from neuroblastoma to the FDA by the end of 2020 or early in 2021. Omburtamab targets tumors that express B7-H3.

Under the agreement, Takeda will be responsible for the sales, access, marketing, and regulatory activities to distribute Danyelza and omburtamab in the territory (State of Israel, West Bank, and Gaza Strip). All other geographies worldwide remain with Y-mAbs.

Financial details of the agreement were not disclosed.

Regulatory Roundup: antibodies, immunotherapies, expanded flu treatment use
Welcome to this week's edition of Regulatory Roundup. This past week, several novel therapies for the treatment of rare diseases and cancers have received...

Copyright © 2020 scienceboard.net

Infectious Diseases (ID) Week 2021
September 29 - October 3
San Diego, California United States
Imaging Mass Spectrometry Society (IMSS) 3 in 2021
October 3-6
Colorado Springs, Colorado United States
Cell & Gene Meeting on the Mesa
October 10-14
Carlsbad, California United States
Science Advisory Board on LinkedIn
Science Advisory Board on Facebook
Science Advisory Board on Twitter